Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial

Weill Medical College of Cornell University2 sites in 1 country9 target enrollmentJuly 5, 2022

ConditionsCardiopulmonary Bypass Surgery

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Cardiopulmonary Bypass Surgery
Sponsor: Weill Medical College of Cornell University
Enrollment: 9
Locations: 2
Primary Endpoint: Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is testing whether pathogen reduced platelets can control bleeding as well as non-pathogen reduced platelets (otherwise known as large volume delayed sampling).

Detailed Description

This is a pilot clinical trial to assess the post-operative bleeding in children who receive pathogen-reduced (PR) platelet transfusions versus standard (large volume delayed sampling - LVDS) platelet transfusions both during and for 24 hours following cardiopulmonary bypass surgery.

Registry

clinicaltrials.gov

Start Date

July 5, 2022

End Date

September 27, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Weill Medical College of Cornell University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female 0 up to and including 18 years of age
•Undergoing elective cardiopulmonary bypass surgery
•Are planned to have a chest tube placed in the operating room prior to chest closure

Exclusion Criteria

•\>/=19 years of age
•Preterm infants (less than 38-week gestational age at time of surgery)
•On extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery
•Family requests limitation of blood products (i.e. Jehovah's Witness)
•Congenital bleeding disorder
•Are planned to require ECMO post-op
•Previously enrolled in the study

Outcomes

Primary Outcomes

Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery

Time Frame: Within the first 24 hours post-op.

Chest tube output for first 24 hours following cardiopulmonary bypass surgery

Secondary Outcomes

Total Dose Red Blood Cell Volume Transfused in First 48 Hours Post-op(During hospitalization in the first 48 hours (no follow-up visits necessary))
Total Platelet Volume Transfused in the First 48 Hours Post-op(During hospitalization in the first 48 hours (no follow-up visits necessary))
Total Plasma Volume Transfused in the First 48 Hours Post-op(During hospitalization in the first 48 hours (no follow-up visits necessary))
Total Cryoprecipitate Volume Transfused in the First 48 Hours Post-op.(During hospitalization in the first 48 hours (no follow-up visits necessary))